Loperamide
As of the edition of 20 October 2026, Loperamide is a small molecule: marketed, first approved in 1959 (ES); acts on OPRM1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Imodium
- First approved
- 1 June 1959 (ES)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Bionpharma; 8 holders in all
- Registered trials
- 57, 10 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Pregnancy and women's health; Urinary and reproductive; Hormones
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Loperamide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 3 | 2 | 2 |
| Phase 1 | 14 | 10 | 4 | 0 |
| Phase 2 | 15 | 9 | 2 | 3 |
| Phase 3 | 11 | 5 | 0 | 4 |
| Phase 4 | 8 | 5 | 2 | 1 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Acquired holder, Later holder, Earlier holder and Lead sponsor of trials | 1988 to now |
| Bausch Health | Acquired holder | 1996 to now |
| Bionpharma | Acquired holder | 2016 to now |
| Kenvue Brands | Acquired holder | 2025 to now |